23 May 2016 EMA/CHMP/349943/2016 Procedure Management and Committees Support Division

Committee for medicinal products for human use (CHMP) Draft agenda for the meeting on 23-26 May 2016 Chair: Tomas Salmonson – Vice-Chair: Pierre Demolis 23 May 2016, 13:00 – 19:30, room 2A 24 May 2016, 08:30 – 19:30, room 2A 25 May 2016, 08:30 – 19:30, room 2A 26 May 2016, 08:30 – 15:00, room 2A

Health and safety information In accordance with the Agency’s health and safety policy, delegates are to be briefed on health, safety and emergency information and procedures prior to the start of the meeting. Disclaimers Some of the information contained in this agenda is considered commercially confidential or sensitive and therefore not disclosed. With regard to intended therapeutic indications or procedure scopes listed against products, it must be noted that these may not reflect the full wording proposed by applicants and may also vary during the course of the review. Additional details on some of these procedures will be published in the CHMP meeting highlights once the procedures are finalised and start of referrals will also be available. Of note, this agenda is a working document primarily designed for CHMP members and the work the Committee undertakes. Note on access to documents Some documents mentioned in the agenda cannot be released at present following a request for access to documents within the framework of Regulation (EC) No 1049/2001 as they are subject to on-going procedures for which a final decision has not yet been adopted. They will become public when adopted or considered public according to the principles stated in the Agency policy on access to documents (EMA/127362/2006).

30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5520 Send a question via our website www.ema.europa.eu/contact

An agency of the European Union

© European Medicines Agency, 2016. Reproduction is authorised provided the source is acknowledged.

Table of contents 1.

Introduction

1.1.

Welcome and declarations of interest of members, alternates and experts ............ 7

1.2.

Adoption of agenda................................................................................................. 7

1.3.

Adoption of the minutes ......................................................................................... 7

2.

Oral Explanations

2.1.

Pre-authorisation procedure oral explanations ....................................................... 7

2.1.1.

- amikacin - Orphan - EMEA/H/C/003936 ..................................................................... 7

2.1.2.

- drisapersen - Orphan - EMEA/H/C/003846.................................................................. 7

2.2.

Re-examination procedure oral explanations ......................................................... 8

2.3.

Post-authorisation procedure oral explanations ..................................................... 8

2.3.1.

Arzerra - ofatumumab - Orphan - EMEA/H/C/001131/II/0041 ......................................... 8

2.4.

Referral procedure oral explanations...................................................................... 8

3.

Initial applications

3.1.

Initial applications; Opinions .................................................................................. 8

3.1.1.

- bortezomib - EMEA/H/C/004207 ................................................................................ 8

3.1.2.

- bortezomib - EMEA/H/C/004076 ................................................................................ 8

3.1.3.

- sofosbuvir / velpatasvir - EMEA/H/C/004210............................................................... 9

3.1.4.

- ixazomib - Orphan - EMEA/H/C/003844 ..................................................................... 9

3.1.5.

- pemetrexed - EMEA/H/C/003895............................................................................... 9

3.1.6.

- saxagliptin / dapagliflozin - EMEA/H/C/004057 ............................................................ 9

3.1.7.

- grazoprevir / elbasvir - EMEA/H/C/004126 ................................................................. 9

3.2.

Initial applications; Day 180 list of outstanding issues ......................................... 10

3.2.1.

- darunavir - EMEA/H/C/004068 ................................................................................ 10

3.2.2.

- emtricitabine / tenofovir disoproxil - EMEA/H/C/004050 ............................................. 10

3.2.3.

- dinutuximab beta - Orphan - EMEA/H/C/003918 ....................................................... 10

3.2.4.

- tenofovir disoproxil - EMEA/H/C/004049................................................................... 10

3.2.5.

- tenofovir disoproxil - EMEA/H/C/004120................................................................... 10

3.2.6.

- eluxadoline - EMEA/H/C/004098.............................................................................. 11

3.3.

Initial applications; Day 120 list of questions ....................................................... 11

3.3.1.

- cabozantinib - EMEA/H/C/004163 ............................................................................ 11

3.3.2.

- prasterone - EMEA/H/C/004138 .............................................................................. 11

3.3.3.

- lenvatinib - EMEA/H/C/004224 ................................................................................ 11

3.3.4.

- nonacog beta pegol - Orphan - EMEA/H/C/004178 .................................................... 11

3.3.5.

- tadalafil - EMEA/H/C/004297 .................................................................................. 12

3.3.6.

- padeliporfin - EMEA/H/C/004182 ............................................................................. 12

Committee for medicinal products for human use (CHMP) EMA/CHMP/349943/2016

7

7

8

Page 2/34

3.3.7.

- pegfilgrastim - EMEA/H/C/004211 ........................................................................... 12

3.4.

Update on on-going initial applications for Centralised procedure ........................ 12

3.4.1.

- ertapenem - EMEA/H/C/004080 .............................................................................. 12

3.4.2.

- allogeneic t cells genetically modified to express suicide gene - Orphan - ATMP EMEA/H/C/002801 ................................................................................................... 12

3.4.3.

- vosaroxin - Orphan - EMEA/H/C/004118 .................................................................. 13

3.5.

Re-examination of initial application procedures under Article 9(2) of Regulation no 726/2004 ........................................................................................................ 13

3.5.1.

Sialanar - glycopyrronium bromide - PUMA - EMEA/H/C/003883 .................................... 13

3.6.

Initial applications in the decision-making phase ................................................. 13

3.7.

Withdrawals of initial marketing authorisation application .................................. 13

3.7.1.

Opsiria - sirolimus - Orphan - EMEA/H/C/003978......................................................... 13

4.

Extension of marketing authorisation according to Annex I of Commission Regulation (EC) No 1234/2008

4.1.

Extension of marketing authorisation according to Annex I of Commission Regulation (EC) No 1234/2008; Opinion .............................................................. 14

4.1.1.

Repatha - evolocumab - EMEA/H/C/003766/X/0002 ..................................................... 14

4.2.

Extension of marketing authorisation according to Annex I of Commission Regulation (EC) No 1234/2008; Day 180 list of outstanding issues ..................... 14

4.2.1.

Fycompa - perampanel - EMEA/H/C/002434/X/0025 .................................................... 14

4.3.

Extension of marketing authorisation according to Annex I of Commission Regulation (EC) No 1234/2008; Day 120 List of question .................................... 14

4.3.1.

Ruconest - conestat alfa - EMEA/H/C/001223/X/0034 .................................................. 14

4.3.2.

Tivicay - dolutegravir - EMEA/H/C/002753/X/0018/G ................................................... 15

4.3.3.

Zytiga - abiraterone - EMEA/H/C/002321/X/0039 ........................................................ 15

4.4.

Update on on-going extension application according to Annex I of Commission Regulation (EC) No 1234/2008 ............................................................................ 15

4.5.

Re-examination procedure of extension of marketing authorisation according to Annex I of Commission Regulation (EC) No 1234/2008 ....................................... 15

5.

Type II variations - variation of therapeutic indication procedure according to Annex I of Commission Regulation (EC) No 1234/2008 15

5.1.

Type II variations - variation of therapeutic indication procedure according to Commission Regulation (EC) No 1234/2008; Opinions or Requests for supplementary information .................................................................................. 15

5.1.1.

Adcetris - brentuximab vedotin - Orphan - EMEA/H/C/002455/II/0025 ........................... 15

5.1.2.

Humira - adalimumab - EMEA/H/C/000481/II/0146 ..................................................... 16

5.1.3.

Kyprolis - carfilzomib - Orphan - EMEA/H/C/003790/II/0001/G ..................................... 16

5.1.4.

Lucentis - ranibizumab - EMEA/H/C/000715/II/0061 .................................................... 16

5.1.5.

Revestive - teduglutide - Orphan - EMEA/H/C/002345/II/0020 ...................................... 17

5.1.6.

Synjardy - empagliflozin / metformin - EMEA/H/C/003770/II/0015 ................................ 17

Committee for medicinal products for human use (CHMP) EMA/CHMP/349943/2016

14

Page 3/34

5.1.7.

Translarna - ataluren - Orphan - EMEA/H/C/002720/II/0012......................................... 17

5.1.8.

Tysabri - natalizumab - EMEA/H/C/000603/II/0077 ..................................................... 18

5.1.9.

Xalkori - crizotinib - EMEA/H/C/002489/II/0039 .......................................................... 18

5.1.10.

Trajenta Jentadueto - linagliptin - EMEA/H/C/WS0915 .................................................. 18

5.2.

Update on on-going Type II variation; variation of therapeutic indication procedure according to Commission Regulation (EC) No 1234/2008 ................... 19

5.3.

Re-examination of Type II variation; variation of therapeutic indication procedure according to Commission Regulation (EC) No 1234/2008 .................................... 19

6.

Ancillary medicinal substances in medical devices

6.1.

Ancillary medicinal substances in medical devices; Opinions/ Day 180 list of outstanding issues / Day 120 list of questions ..................................................... 19

6.2.

Update of Ancillary medicinal substances in medical devices ............................... 19

7.

Procedure under Article 83(1) of Regulation (EC) 726/2004 (Compassionate Use)

7.1.

Procedure under Article 83(1) of Regulation (EC) 726/2004 (Compassionate Use) ............................................................................................................................. 19

8.

Pre-submission issues

8.1.

Pre-submission issue ............................................................................................ 19

8.1.1.

- GLIBENCLAMIDE - Orphan - H0004379 .................................................................... 19

8.1.2.

Briefing note and Rapporteurs’ recommendation on the request for accelerated assessment. - Etirinotecan Pegol - H0003874 ................................................................................ 20

8.1.3.

Briefing note and Rapporteurs’ recommendation on the request for accelerated assessment. - MIDOSTAURIN - Orphan - H0004095 ....................................................................... 20

8.2.

Priority Medicines (PRIME) ................................................................................... 20

8.2.1.

List of applications received ...................................................................................... 20

8.2.2.

Recommendation for PRIME eligibility ......................................................................... 20

8.2.3.

Fee reductions for scientific advice requests on PRIME products for SMEs and applicants from the academic sector ......................................................................................... 20

9.

Post-authorisation issues

9.1.

Post-authorisation issues ..................................................................................... 21

9.1.1.

Simponi - golimumab - EMEA/H/C/000992/II/0063 ...................................................... 21

9.1.2.

Revatio - sildenafil - EMEA/H/C/000638/II/0073 .......................................................... 21

10.

Referral procedures

10.1.

Procedure for Centrally Authorised products under Article 20 Council Regulation (EC) No 726/2004 ................................................................................................ 22

10.2.

Requests for CHMP Opinion under Article 5(3) of Regulation (EC) No 726/2004.. 22

10.2.1.

Desloratadine-containing products ............................................................................. 22

10.3.

Procedure under Articles 5(2) and 10 of the Regulation (EC) No 726/2004 ......... 22

Committee for medicinal products for human use (CHMP) EMA/CHMP/349943/2016

19

19

19

21

22

Page 4/34

10.4.

Disagreement between Member States on application for medicinal product (potential serious risk to public health) –under Article 29(4) of Directive 2001/83/EC ......................................................................................................... 22

10.4.1.

Diclofenac 50 mg Tablets - Diclofenac epolamine - EMEA/H/A-29/1434 .......................... 22

10.5.

Harmonisation - Referral procedure under Article 30 of Directive 2001/83/EC .... 23

10.6.

Community Interests - Referral under Article 31 of Directive 2001/83/EC .......... 23

10.6.1.

Dienogest/Ethinylestradiol containing products indicated in acne - Dienogest / EMEA/H/A31/ 1435 ................................................................................................................ 23

10.6.2.

Symbioflor 2, Escherichia Coli bacteria (cells and autolysate) - EMEA/H/A-31/1441 ......... 23

10.6.3.

Semler Research Centre Private Ltd - EMEA/H/A-31/1443 ............................................ 24

10.7.

Re-examination Procedure under Article 32(4) of Directive 2001/83/EC ............. 24

10.8.

Procedure under Article 107(2) of Directive 2001/83/EC .................................... 24

10.9.

Disagreement between Member States on Type II variation– Arbitration procedure initiated by MAH under Article 6(13) (EC) No 1084/2003 .................................... 24

10.10.

Procedure under Article 29 Regulation (EC) 1901/2006....................................... 24

10.11.

Referral under Article 13 Disagreement between Member States on Type II variation– Arbitration procedure initiated by Member State under Article 13 (EC) No 1234/2008)..................................................................................................... 24

10.11.1.

Levonelle 1500mcg tablets and associated names – Levonorgestrel - EMEA/H/A-13/1427. 24

11.

Pharmacovigilance issue

11.1.

Early Notification System...................................................................................... 25

12.

Inspections

12.1.

GMP inspections ................................................................................................... 25

12.2.

GCP inspections .................................................................................................... 25

12.3.

Pharmacovigilance inspections ............................................................................. 25

12.4.

GLP inspections .................................................................................................... 25

13.

Innovation Task Force

13.1.

Minutes of Innovation Task Force ......................................................................... 25

13.2.

Innovation Task Force briefing meetings.............................................................. 25

13.3.

Requests for CHMP Opinion under Article 57(1)J and (1)P of Regulation (EC) No 726/2004 ............................................................................................................. 26

13.4.

Nanomedicines activities ...................................................................................... 27

14.

Organisational, regulatory and methodological matters

14.1.

Mandate and organisation of the CHMP ................................................................ 27

14.1.1.

Confirmation of area of expertise of Co-opted Member ................................................. 27

14.1.2.

Assessment Report templates for Generic products ...................................................... 27

14.1.3.

Feedback from recent interactions on evaluation management ...................................... 27

14.1.4.

Confirmation of joint CHMP/PDCO membership for Hungary, Romania, Luxembourg ........ 27

Committee for medicinal products for human use (CHMP) EMA/CHMP/349943/2016

25

25

25

27

Page 5/34

14.1.5.

Update on the “CHMP assessment report on the significant clinical benefit in comparison with existing therapies in accordance with Article 14(11) of Regulation (EC) No 726/2004” and “Practical guidance on elements required to grant an additional year of marketing protection due to significant clinical benefit”................................................................ 27

14.2.

Coordination with EMA Scientific Committees....................................................... 28

14.2.1.

Pharmacovigilance Risk Assessment Committee (PRAC) ............................................... 28

14.2.2.

Committee for Advanced Therapies (CAT) ................................................................... 28

14.2.3.

Committee for Herbal Medicinal Products (HMPC ) ....................................................... 28

14.2.4.

Paediatric Committee (PDCO) .................................................................................... 28

14.2.5.

Committee for Orphan Medicinal Products (COMP) ....................................................... 28

14.2.6.

Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) ............................................................................................................................. 28

14.2.7.

Committee for Medicinal Products for Veterinary Use (CVMP) ........................................ 29

14.3.

Coordination with EMA Working Parties/Working Groups/Drafting Groups ......... 29

14.3.1.

Scientific Advice Working Party (SAWP) ...................................................................... 29

14.3.2.

Gastroenterology Drafting Group ............................................................................... 29

14.3.3.

Safety Working Party (SWP) ..................................................................................... 29

14.3.4.

Radiopharmaceutical Drafting Group (RDG) ................................................................ 29

14.4.

Cooperation within the EU regulatory network ..................................................... 30

14.5.

Cooperation with International Regulators........................................................... 30

14.5.1.

International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) .................................................................................................... 30

14.6.

Contacts of the CHMP with external parties and interaction with the Interested Parties to the Committee ...................................................................................... 31

14.7.

CHMP work plan ................................................................................................... 31

14.8.

Planning and reporting ......................................................................................... 31

14.9.

Others .................................................................................................................. 31

15.

Any other business

15.1.

AOB topic .............................................................................................................. 31

16.

Explanatory notes

Committee for medicinal products for human use (CHMP) EMA/CHMP/349943/2016

31

32

Page 6/34

1.

Introduction

1.1.

Welcome and declarations of interest of members, alternates and experts Pre-meeting list of participants and restrictions in relation to declarations of interests applicable to the items of the agenda for the CHMP plenary session to be held 23-26 May 2016. See May 2016 CHMP minutes (to be published post June 2016 CHMP meeting).

1.2.

Adoption of agenda CHMP agenda for 23-26 May 2016

1.3.

Adoption of the minutes CHMP minutes for 25-28 April 2016.

2.

Oral Explanations

2.1.

Pre-authorisation procedure oral explanations

2.1.1.

- amikacin - Orphan - EMEA/H/C/003936 Insmed Limited; Treatment of Mycobacterium avium Complex (MAC) lung disease in adult patients who have persistent positive sputum cultures despite the use of medically appropriate first-line therapy Scope: Oral explanation Action: Oral explanation to be held on 24 May 2016 at 14.00. List of Outstanding Issues adopted on 25.02.2016. List of Questions adopted on 25.06.2015.

2.1.2.

- drisapersen - Orphan - EMEA/H/C/003846 BioMarin International Limited; treatment of Duchenne muscular dystrophy (DMD) Scope: Oral explanation Action: Possible oral explanation to be held on 24 May 2016 at 9.00. List of Outstanding Issues adopted on 01.04.2016. List of Questions adopted on 22.10.2015. Participation of patients’ representatives

30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5520 Send a question via our website www.ema.europa.eu/contact

An agency of the European Union

© European Medicines Agency, 2016. Reproduction is authorised provided the source is acknowledged.

2.2.

Re-examination procedure oral explanations

2.3.

Post-authorisation procedure oral explanations

2.3.1.

Arzerra - ofatumumab - Orphan - EMEA/H/C/001131/II/0041 Novartis Europharm Ltd Rapporteur: Sinan B. Sarac, Co-Rapporteur: Bjorg Bolstad, PRAC Rapporteur: Doris Stenver Scope: Opinion / Request for Supplementary Information “Extension of Indication to include maintenance therapy in Chronic Lymphocytic Leukemia (CLL). As a consequence, sections 4.1, 4.2, 4.8, 5.1, 5.2 of the SmPC are updated. The Package Leaflet is updated in accordance. In accordance with the new QRD template version 9.1, the MAH is also taking the opportunity of this procedure to update the Annex II and combine the 2 SmPCs for the 100mg and 1,000mg vials.” Action: Possible oral explanation to be held on 24 May 2016 at 11.00. Request for Supplementary Information adopted on 28.04.2016, 25.02.2016, 22.10.2015. SAG Oncology meeting was held on 14 April 2016.

2.4.

Referral procedure oral explanations

3.

Initial applications

3.1.

Initial applications; Opinions

3.1.1.

- bortezomib - EMEA/H/C/004207 treatment of multiple myeloma Scope: Opinion, Similarity assessment report Action: For adoption List of Questions adopted on 28.01.2016. List of Outstanding Issues adopted on 01.04.2016

3.1.2.

- bortezomib - EMEA/H/C/004076 treatment of multiple myeloma Scope: Opinion, Similarity assessment report

Committee for medicinal products for human use (CHMP) EMA/CHMP/349943/2016

Page 8/34

Action: For adoption

List of Outstanding Issues adopted on 01.04.2016, 28.01.2016. List of Questions adopted on 23.07.2015.

3.1.3.

- sofosbuvir / velpatasvir - EMEA/H/C/004210 Accelerated assessment treatment of chronic hepatitis C virus Scope: Opinion Action: For adoption List of Questions adopted on 01.04.2016.

3.1.4.

- ixazomib - Orphan - EMEA/H/C/003844 Takeda Pharma A/S; multiple myeloma Scope: Opinion Action: For adoption List of Outstanding Issues adopted on 01.04.2016, 25.02.2016. List of Questions adopted on 17.12.2015. Oral explanation held on 26.0.4.2016.

3.1.5.

- pemetrexed - EMEA/H/C/003895 treatment of malignant pleural mesothelioma and non-small cell lung cancer Scope: Opinion Action: For adoption List of Outstanding Issues adopted on 01.04.2016. List of Questions adopted on 22.10.2015.

3.1.6.

- saxagliptin / dapagliflozin - EMEA/H/C/004057 treatment of type 2 diabetes Scope: Opinion Action: For adoption List of Outstanding Issues adopted on 28.04.2016, 25.02.2016. List of Questions adopted on 24.09.2015.

3.1.7.

- grazoprevir / elbasvir - EMEA/H/C/004126 treatment of chronic hepatitis C (CHC) in adults Scope: Opinion

Committee for medicinal products for human use (CHMP) EMA/CHMP/349943/2016

Page 9/34

Action: For adoption

List of Outstanding Issues adopted on 01.04.2016, 25.02.2016. List of Questions adopted on 19.11.2015.

3.2. 3.2.1.

Initial applications; Day 180 list of outstanding issues - darunavir - EMEA/H/C/004068 treatment of HIV-1 Scope: Day 180 list of outstanding issue Action: For adoption List of Questions adopted on 17.12.2015.

3.2.2.

- emtricitabine / tenofovir disoproxil - EMEA/H/C/004050 treatment of HIV Scope: Day 180 list of outstanding issue Action: For adoption List of Questions adopted on 19.11.2015.

3.2.3.

- dinutuximab beta - Orphan - EMEA/H/C/003918 APEIRON Biologics AG; treatment of neuroblastoma Scope: Day 180 list of outstanding issue Action: For adoption List of Questions adopted on 24.09.2015. BWP Report

3.2.4.

- tenofovir disoproxil - EMEA/H/C/004049 treatment of HIV-1 infection and hepatitis B infection Scope: Day 180 list of outstanding issue Action: For adoption List of Questions adopted on 17.12.2015.

3.2.5.

- tenofovir disoproxil - EMEA/H/C/004120 treatment of HIV-1 infection and hepatitis B infection Scope: Day 180 list of outstanding issue

Committee for medicinal products for human use (CHMP) EMA/CHMP/349943/2016

Page 10/34

Action: For adoption List of Questions adopted on 28.01.2016.

3.2.6.

- eluxadoline - EMEA/H/C/004098 for the treatment of irritable bowel syndrome with diarrhoea Scope: Day 180 list of outstanding issue Action: For adoption List of Questions adopted on 24.09.2015.

3.3. 3.3.1.

Initial applications; Day 120 list of questions - cabozantinib - EMEA/H/C/004163 Accelerated assessment treatment of advanced renal cell carcinoma (RCC) Scope: Day 120 list of questions Action: For adoption

3.3.2.

- prasterone - EMEA/H/C/004138 treatment of vulvovaginal atrophy Scope: Day 120 list of questions Action: For adoption

3.3.3.

- lenvatinib - EMEA/H/C/004224 Accelerated assessment in combination with everolimus for the treatment of unresectable advanced or metastatic renal cell carcinoma (RCC) Scope: Day 120 list of questions Action: For adoption

3.3.4.

- nonacog beta pegol - Orphan - EMEA/H/C/004178 Novo Nordisk A/S; treatment of haemophilia B Scope: Day 120 list of questions Action: For adoption BWP Report

Committee for medicinal products for human use (CHMP) EMA/CHMP/349943/2016

Page 11/34

3.3.5.

- tadalafil - EMEA/H/C/004297 treatment of pulmonary arterial hypertension (PAH)

Scope: Day 120 list of questions Action: For adoption

3.3.6.

- padeliporfin - EMEA/H/C/004182 treatment of prostate cancer Scope: Day 120 list of questions Action: For adoption

3.3.7.

- pegfilgrastim - EMEA/H/C/004211 treatment of neutropenia Scope: Day 120 list of questions Action: For adoption BWP Report

3.4. 3.4.1.

Update on on-going initial applications for Centralised procedure - ertapenem - EMEA/H/C/004080 treatment of bacterial infections and prophylaxis of surgical site infection following elective colorectal surgery Scope: Request for an extension to the clock stop to respond to the Day 120 List of questions adopted in February 2016. Action: For adoption List of Questions adopted on 25.02.2016

3.4.2.

- allogeneic t cells genetically modified to express suicide gene - Orphan - ATMP - EMEA/H/C/002801 MolMed SpA; treatment in haploidentical haematopoietic stem cell transplantation Scope: Update on procedure, Oral Explanation held at CAT on 18.05.2016 Action: For information List of Outstanding Issues adopted on 01.04.2016, 28.01.2016, 26.03.2015. List of Questions adopted on 24.07.2014. BWP Report

Committee for medicinal products for human use (CHMP) EMA/CHMP/349943/2016

Page 12/34

3.4.3.

- vosaroxin - Orphan - EMEA/H/C/004118 Sunesis Europe Ltd; treatment acute myeloid leukaemia Scope: Request for an extension to the clock stop to respond to the Day 120 List of questions adopted in April 2016. Action: For adoption List of Questions adopted on 28.04.2016.

3.5.

Re-examination of initial application procedures under Article 9(2) of Regulation no 726/2004

3.5.1.

Sialanar - glycopyrronium bromide - PUMA - EMEA/H/C/003883 Proveca Limited; treatment of sialorrhoea Scope: Letter from the applicant dated May 2016 requesting a re-examination of the Opinion adopted on 28.04.2016. Appointment of re-examination Rapporteurs Action: Appointment of re-examination Rapporteurs The Committee appointed Kristina Dunder as Re-examination Rapporteur and Arantxa Sancho Lopez as the re-examination Co-Rapporteur by written procedure on 17 May 2016. The PRAC Rapporteur remains the same for the initial evaluation.

3.6.

Initial applications in the decision-making phase

3.7.

Withdrawals of initial marketing authorisation application

3.7.1.

Opsiria - sirolimus - Orphan - EMEA/H/C/003978 Santen Oy; treatment of chronic non-infectious uveitis Scope: Letter from the applicant dated 20 May 2016 informing of the decision to withdraw the MAA. Action: For information

Committee for medicinal products for human use (CHMP) EMA/CHMP/349943/2016

Page 13/34

4.

Extension of marketing authorisation according to Annex I of Commission Regulation (EC) No 1234/2008

4.1.

Extension of marketing authorisation according to Annex I of Commission Regulation (EC) No 1234/2008; Opinion

4.1.1.

Repatha - evolocumab - EMEA/H/C/003766/X/0002 Amgen Europe B.V. Rapporteur: Pieter de Graeff, PRAC Rapporteur: Kimmo Jaakkola Scope: “To add a new strength of 420 mg (120 mg/mL) for evolocumab solution for injection in cartridge, for subcutaneous (SC) administration by an automated mini-doser device.” Action: For adoption List of Questions adopted on 25.02.2016.

4.2.

Extension of marketing authorisation according to Annex I of Commission Regulation (EC) No 1234/2008; Day 180 list of outstanding issues

4.2.1.

Fycompa - perampanel - EMEA/H/C/002434/X/0025 Eisai Europe Ltd. Scope: “To add a new pharmaceutical form, oral solution, to the one currently approved (EU/1/12/776/024). To add a new strength of 0.5 mg/ml for Fycompa finished product (EU/1/12/776/024).” Action: For adoption List of Questions adopted on 17.12.2015.

4.3.

Extension of marketing authorisation according to Annex I of Commission Regulation (EC) No 1234/2008; Day 120 List of question

4.3.1.

Ruconest - conestat alfa - EMEA/H/C/001223/X/0034 Pharming Group N.V Rapporteur: Nithyanandan Nagercoil, Scope: “Addition of a new pharmaceutical form "powder and solvent for solution for injection" with self-administration kit.” Action: For adoption

Committee for medicinal products for human use (CHMP) EMA/CHMP/349943/2016

Page 14/34

4.3.2.

Tivicay - dolutegravir - EMEA/H/C/002753/X/0018/G ViiV Healthcare UK Limited Rapporteur: Filip Josephson, Co-Rapporteur: Joseph Emmerich, PRAC Rapporteur: Julie Williams Scope: “An extension application to add two new strengths (10mg and 25mg tablets) to support the extension (variation type II C.I.6) of the target population covered by the authorised therapeutic indication for Tivicay to treat paediatric patients from 6 years of age infected with HIV. Data from cohort I and II A of the clinical trial ING112578 are presented in support of the new therapeutic indication.” Action: For adoption

4.3.3.

Zytiga - abiraterone - EMEA/H/C/002321/X/0039 Janssen-Cilag International N.V. Rapporteur: Arantxa Sancho-Lopez, Scope: “Extension application to introduce a new pharmaceutical form associated with new strength (500mg film-coated tablets).” Action: For adoption

4.4.

Update on on-going extension application according to Annex I of Commission Regulation (EC) No 1234/2008

4.5.

Re-examination procedure of extension of marketing authorisation according to Annex I of Commission Regulation (EC) No 1234/2008

5.

Type II variations - variation of therapeutic indication procedure according to Annex I of Commission Regulation (EC) No 1234/2008

5.1.

Type II variations - variation of therapeutic indication procedure according to Commission Regulation (EC) No 1234/2008; Opinions or Requests for supplementary information

5.1.1.

Adcetris - brentuximab vedotin - Orphan - EMEA/H/C/002455/II/0025 Takeda Pharma A/S Rapporteur: Pieter de Graeff, Co-Rapporteur: Jan Mueller-Berghaus, PRAC Rapporteur: Sabine Straus Scope: “Extension of Indication to include new indication for Adcetris (for the treatment of adult patients at increased risk of relapse or progression following ASCT”), as a consequence, sections 4.1, 4.2, 4.4, 4.8 and 5.1 of the SmPC are updated. The Package

Committee for medicinal products for human use (CHMP) EMA/CHMP/349943/2016

Page 15/34

Leaflet is updated in accordance.” Request for 1 year of market protection for a new indication (Article 14(11) of Regulation (EC) 726/2004). Action: For adoption Request for Supplementary Information adopted on 28.04.2016, 01.04.2016, 22.10.2015, 25.06.2015.

5.1.2.

Humira - adalimumab - EMEA/H/C/000481/II/0146 AbbVie Ltd. Rapporteur: Kristina Dunder, Co-Rapporteur: Daniela Melchiorri, PRAC Rapporteur: Ulla Wändel Liminga Scope: “Extension of Indication to include treatment of non-infectious intermediate, posterior and panuveitis in adult patients for Humira. As a consequence, sections 4.1, 4.2, 4.4, 4.8, 5.1 and 5.2 of the SmPC are updated. The Package Leaflet is updated in accordance.” Action: For adoption Request for Supplementary Information adopted on 28.04.2016, 17.12.2015.

5.1.3.

Kyprolis - carfilzomib - Orphan - EMEA/H/C/003790/II/0001/G Amgen Europe B.V. Rapporteur: Arantxa Sancho-Lopez, Scope: “Extension of Indication to include new indication for Kyprolis to be used with either lenalidomide and dexamethasone or dexamethasone alone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. As a consequence, sections 4.1, 4.2, 4.8, 5.1 and 5.2 of the SmPC are updated. The Package Leaflet is updated in accordance. In addition, the Marketing authorisation holder (MAH) updated section 6.6 of the SmPC to include the option to administer Kyprolis in a 100 mL intravenous bag containing 5% glucose solution for injection in line with the extension of indication part of this variation. Furthermore the MAH took the opportunity to include some editorial changes and harmonisations in the PI.” Action: For adoption Request for Supplementary Information adopted on 01.04.2016.

5.1.4.

Lucentis - ranibizumab - EMEA/H/C/000715/II/0061 Novartis Europharm Ltd Rapporteur: Kristina Dunder, Co-Rapporteur: Concepcion Prieto Yerro, PRAC Rapporteur: Ulla Wändel Liminga Scope: “Extension of Indication to include treatment of visual impairment due to choroidal neovascularization (CNV) based on 6-month data from the pivotal study CRFB002G2301 (MINERVA). Consequential changes are proposed to SmPC sections 4.1, 4.2, 4.8 and 5.1 and the Package Leaflet is proposed to be updated accordingly.

Committee for medicinal products for human use (CHMP) EMA/CHMP/349943/2016

Page 16/34

The application included an updated RMP version 16.0.” Action: For adoption

5.1.5.

Revestive - teduglutide - Orphan - EMEA/H/C/002345/II/0020 NPS Pharma Holdings Limited Rapporteur: Sinan B. Sarac, PRAC Rapporteur: Torbjorn Callreus Scope: “Extension of Indication to include paediatric population for Revestive. As a consequence, sections 4.1, 4.2, 4.4, 4.8, 5.1, 5.2 and 6.6 of the SmPC are updated in order to update the safety information. The Package Leaflet is updated in accordance.” Action: For adoption Request for Supplementary Information adopted on 01.04.2016, 19.11.2015.

5.1.6.

Synjardy - empagliflozin / metformin - EMEA/H/C/003770/II/0015 Boehringer Ingelheim GmbH Rapporteur: Pieter de Graeff, Co-Rapporteur: Daniela Melchiorri, PRAC Rapporteur: Miguel-Angel Macia Scope: “Extension of Indication to include treatment with Synjardy as adjunct to standard care therapy in adult patients with type 2 diabetes mellitus and high cardiovascular risk when treatment with empagliflozin and metformin is appropriate and empagliflozin is needed to reduce the risk of all-cause mortality by reducing cardiovascular death and cardiovascular death or hospitalization for heart failure. As a consequence, sections 4.1, 4.4, 4.8 and 5.1 of the SmPC are updated based on the final CSR of study EMPA-REG OUTCOME. The Package Leaflet is updated accordingly. In addition, the Marketing authorisation holder (MAH) took the opportunity to make minor editorial changes/corrections in the SmPC. Moreover, the updated RMP version 5.0 has been submitted.” Action: For adoption

5.1.7.

Translarna - ataluren - Orphan - EMEA/H/C/002720/II/0012 PTC Therapeutics International Limited Rapporteur: Johann Lodewijk Hillege, Co-Rapporteur: Concepcion Prieto Yerro, PRAC Rapporteur: Sabine Straus Scope: “Extension of indication for Translarna to include the treatment of cystic fibrosis resulting from a nonsense mutation in at least one allele of the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Consequently, sections 4.1, 4.2, 4.3, 4.4, 4.5, 4.8, 5.1, 5.2 of the SmPC were updated. The Package leaflet and RMP are being updated accordingly. The MAH took also the opportunity to implement the QRD template v9.1. and proposed combined SmPC for Translarna 125 mg, 250 mg and 1000 mg granules for oral suspension. Minor editorial changes have been introduced throughout the PI.”, Request for 1 year of market protection for a new indication (Article 14(11) of Regulation (EC)

Committee for medicinal products for human use (CHMP) EMA/CHMP/349943/2016

Page 17/34

726/2004) Action: For adoption Request for Supplementary Information adopted on 17.12.2015.

5.1.8.

Tysabri - natalizumab - EMEA/H/C/000603/II/0077 Biogen Idec Ltd Rapporteur: Jan Mueller-Berghaus, Co-Rapporteur: Daniela Melchiorri, PRAC Rapporteur: Brigitte Keller-Stanislawski Scope: “Extension of Indication to include new indication for Tysabri. As a consequence, sections 4.1 AND 4.4 of the SmPC are updated in order to provide physicians with more options for treating RRMS patients with high disease activity who fail an initial disease modifying therapy (DMT). Consequential changes to sections 4.2, 4.3, 5.1 and Package Leaflet in Sections 2 and 3 are also proposed.” Action: For adoption Request for Supplementary Information adopted on 01.04.2016, 19.11.2015, 25.06.2015.

5.1.9.

Xalkori - crizotinib - EMEA/H/C/002489/II/0039 Pfizer Limited Rapporteur: Pierre Demolis, Co-Rapporteur: Daniela Melchiorri, PRAC Rapporteur: Isabelle Robine Scope: “Extension of Indication to include treatment of adults with ROS1-positive advanced non-small cell lung cancer (NSCLC) based on the results of Study A8081001 (a multinational, multicentre, open-label, single-arm study of the safety, pharmacokinetics, pharmacodynamics, and antitumor activity of crizotinib in patients with advanced cancer). Consequential changes are proposed to SmPC sections 4.1, 4.2, 4.4, 4.8, 5.1 and 5.2 and the Package Leaflet is proposed to be updated accordingly. In addition, the MAH took the opportunity to implement minor editorial changes in the SmPC and Annex II. The application included an updated RMP version 7.0.” Action: For adoption

5.1.10.

Trajenta Jentadueto - linagliptin - EMEA/H/C/WS0915 Boehringer Ingelheim International GmbH Lead Rapporteur: Pieter de Graeff, PRAC Rapporteur: Menno van der Elst Scope: “Extension of Indication to include use of Trajenta as combination therapy with metformin and an SGLT-2 inhibitor and use of Jentadueto as combination therapy with an SGLT-2 inhibitor. As a consequence, sections 4.1, 4.8 and 5.1 of the SmPC are updated based on studies 1245.30, 1275.10 and 1275.1. The Package Leaflet is updated accordingly. In addition, the Worksharing applicant (WSA) took the opportunity to make minor editorial changes in the SmPC for Jentadueto only. Moreover, the updated RMP version 10 (for Trajenta) and version 12 (for Jentadueto) have been submitted.”

Committee for medicinal products for human use (CHMP) EMA/CHMP/349943/2016

Page 18/34

Action: For adoption

5.2.

Update on on-going Type II variation; variation of therapeutic indication procedure according to Commission Regulation (EC) No 1234/2008

5.3.

Re-examination of Type II variation; variation of therapeutic indication procedure according to Commission Regulation (EC) No 1234/2008

6.

Ancillary medicinal substances in medical devices

6.1.

Ancillary medicinal substances in medical devices; Opinions/ Day 180 list of outstanding issues / Day 120 list of questions

6.2.

Update of Ancillary medicinal substances in medical devices

7.

Procedure under Article 83(1) of Regulation (EC) 726/2004 (Compassionate Use)

7.1.

Procedure under Article 83(1) of Regulation (EC) 726/2004 (Compassionate Use)

8.

Pre-submission issues

8.1.

Pre-submission issue

8.1.1.

- glibenclamide - Orphan - H0004379 AmmTek; Treatment of neonatal diabetes, paediatric formulation (ready to use oral suspension of glibenclamide) to be used in newborns, infants and children. Scope: Letter from the company dated 30 March 2016 requesting an accelerated assessment Action: For adoption Briefing note and Rapporteurs’ recommendation on the request for accelerated assessment.

Committee for medicinal products for human use (CHMP) EMA/CHMP/349943/2016

Page 19/34

8.1.2.

- etirinotecan Pegol - H0003874 indicated for the treatment of patients with locally recurrent or metastatic breast cancer (MBC). Prior therapy should have included an anthracycline, a taxane and capecitabine (ATC). Scope: Letter from the company dated 3 May 2016 requesting an accelerated assessment Action: For adoption Briefing note and Rapporteurs’ recommendation on the request for accelerated assessment.

8.1.3.

- midostaurin - Orphan - H0004095 Novartis Europharm Ltd; indicated as a combination therapy for the treatment of patients with newly diagnosed acute myeloid leukaemia who are FLT3 mutation-positive and who are eligible to receive standard induction and consolidation chemotherapy; indicated for the treatment of patients with aggressive systemic mastocytosis (ASM) or mast cell leukemia (MCL) with or without an associated hematologic non-mast cell lineage disorder (AHNMD). Scope: Letter from the company dated 4 May 2016 requesting an accelerated assessment Action: For adoption Briefing note and Rapporteurs’ recommendation on the request for accelerated assessment.

8.2.

Priority Medicines (PRIME) Disclosure of information related to priority medicines cannot be released at present time as these contain commercially confidential information

8.2.1.

List of applications received Action: For information

8.2.2.

Recommendation for PRIME eligibility Action: For adoption

8.2.3.

Fee reductions for scientific advice requests on PRIME products for SMEs and applicants from the academic sector Executive Director decision on fee reductions for scientific advice requests on PRIME products for SMEs and applicants from the academic sector

Committee for medicinal products for human use (CHMP) EMA/CHMP/349943/2016

Page 20/34

Action: For adoption

9.

Post-authorisation issues

9.1.

Post-authorisation issues

9.1.1.

Simponi - golimumab - EMEA/H/C/000992/II/0063 MAH: Janssen Biologics B.V., Rapporteur: Kristina Dunder, PRAC Rapporteur: Ulla Wändel Liminga, Scope: Opinion “Update of the SmPC sections 4.2 and 5.1 in order to reflect the data from a multicentre, placebo-controlled, double-blind, randomised-withdrawal, parallel group study (GO KIDS) in children (2 to 17 years of age) with active polyarticular juvenile idiopathic arthritis (pJIA). The Package leaflet is proposed to be updated accordingly. This procedure includes also an update to the RMP.” Action: For adoption Request for Supplementary Information adopted on 01.04.2016, 19.11.2015, 26.03.2015.

9.1.2.

Revatio - sildenafil - EMEA/H/C/000638/II/0073 MAH: Pfizer Limited, Rapporteur: Pieter de Graeff, Scope: Opinion “Following the availability of powder for oral suspension formulation and following the request of CHMP, update of sections 4.2, 6.3, 6.4 and 6.6 of Revatio 20mg film-coated tablets SmPC and section 4.2 of Revatio 10mg powder for oral suspension to delete information related to the extemporaneously prepared oral suspension. The film-coated tablet PL is updated accordingly.” Action: For adoption

Committee for medicinal products for human use (CHMP) EMA/CHMP/349943/2016

Page 21/34

10.

Referral procedures

10.1.

Procedure for Centrally Authorised products under Article 20 Council Regulation (EC) No 726/2004

10.2.

Requests for CHMP Opinion under Article 5(3) of Regulation (EC) No 726/2004

10.2.1.

Desloratadine-containing products Rapporteur: Daniel Brasseur, Co-Rapporteur: Andrea Laslop Scope: Opinion or List of Outstanding Issues Prescription status of desloratadine-containing products Action: For adoption

10.3.

Procedure under Articles 5(2) and 10 of the Regulation (EC) No 726/2004

10.4.

Disagreement between Member States on application for medicinal product (potential serious risk to public health) –under Article 29(4) of Directive 2001/83/EC

10.4.1.

Diclofenac 50 mg Tablets - Diclofenac epolamine - EMEA/H/A-29/1434 Altergon Italia srl Rapporteur: Nithyanandan Nagercoil, Co-Rapporteur: Joseph Emmerich, RMS: UK, CMS: CZ, FR, SK Decentralised Procedure number: UK/H/5906/001/DC Scope: List of outstanding Issues / Opinion Disagreements regarding the demonstration of bioequivalence in the fed state Action: For adoption

Committee for medicinal products for human use (CHMP) EMA/CHMP/349943/2016

Page 22/34

10.5.

Harmonisation - Referral procedure under Article 30 of Directive 2001/83/EC

10.6.

Community Interests - Referral under Article 31 of Directive 2001/83/EC

10.6.1. Dienogest/Ethinylestradiol containing products indicated in acne - Dienogest / EMEA/H/A-31/ 1435 Rapporteur: Martina Weise, Co-Rapporteur: Nithyanandan Nagercoil, Scope: Amended timetable Action: For information, adopted via written procedure on 03.05.2016 The CHMP noted a 1-month extension to the timetable adopted by written procedure on 03.05.2016 Re-start of the procedure: 28.04.2016 Rapporteur/co-rapporteur assessment reports circulated to CHMP: 08.06.2016 Comments: 13.06.2016 Updated Rapporteur/co-rapporteur assessment reports circulated to CHMP: 16.06.2016 CHMP list of outstanding issues or Opinion: June 2016 CHMP

10.6.2.

Symbioflor 2, Escherichia Coli bacteria (cells and autolysate) - EMEA/H/A-31/1441 Symbiopharm GmbH, Rapporteur: Harald Enzmann, Co-rapporteur: Milena Stain; Scope: Letter from the MAH dated 4 May 2016 requesting an extension of timeframe to submit responses to the List of Questions adopted on 1 April 2016. Article 31 triggered by the BfArM in Germany in March 2016 requesting the review of the benefit-risk balance for Symbioflor 2 and associated names following concerns that the effectiveness of the medicine(s) has not been adequately demonstrated. Action: Revised timetable adopted by written procedure Submission of responses: 04.08.2016 Re-start of the procedure: 18.08.2016 Rapporteur/co-rapporteur assessment reports circulated to CHMP: 31.08.2016 Comments: 05.09.2016 Updated Rapporteur/co-rapporteur assessment reports circulated to CHMP: 08.09.2016 CHMP LoOI/CHMP opinion: September 2016 CHMP

Committee for medicinal products for human use (CHMP) EMA/CHMP/349943/2016

Page 23/34

10.6.3.

Semler Research Centre Private Ltd - EMEA/H/A-31/1443 Rapporteur: Pieter de Graeff, Co-Rapporteur: Concepcion Prieto-Yerro Scope: Update on the procedure Article 31 referral triggered by the UK, Germany, Spain, Denmark and the Netherlands in relation to findings of non-compliance with GCP at the Semler bioanalytical and clinical facilities in Bangalore, India Action: For information

10.7.

Re-examination Procedure under Article 32(4) of Directive 2001/83/EC

10.8.

Procedure under Article 107(2) of Directive 2001/83/EC

10.9.

Disagreement between Member States on Type II variation– Arbitration procedure initiated by MAH under Article 6(13) (EC) No 1084/2003

10.10.

Procedure under Article 29 Regulation (EC) 1901/2006

10.11.

Referral under Article 13 Disagreement between Member States on Type II variation– Arbitration procedure initiated by Member State under Article 13 (EC) No 1234/2008)

10.11.1. Levonelle 1500mcg tablets and associated names – Levonorgestrel - EMEA/H/A13/1427 MAH: Gedeon Richter Plc Group of companies Rapporteur: Nithyanandan Nagercoil, Co-Rapporteur: Daniela Melchiorri RMS: UK, CMS: AT, BE, CZ, DE, EL, ES, FR, IE, ES, IS, IT, LT, LU, NL, NO, PL, PT, SE, Mutual recognition procedure: UK/H/0803/001/II/022 Scope: Opinion Action: For adoption List of Outstanding Issues adopted on 25 February 2016. List of Questions adopted on 22 October 2015.

Committee for medicinal products for human use (CHMP) EMA/CHMP/349943/2016

Page 24/34

11.

Pharmacovigilance issue

11.1.

Early Notification System May 2016 2016 Early Notification System on envisaged CHMP/CMDh outcome accompanied by communication to the general public Action: For information

12.

Inspections

12.1.

GMP inspections Disclosure of information related to GMP inspections will not be published as it undermines the purpose of such inspections

12.2.

GCP inspections Disclosure of information related to GCP inspections will not be published as it undermines the purpose of such inspections

12.3.

Pharmacovigilance inspections Disclosure of information related to Pharmacovigilance inspections will not be published as it undermines the purpose of such inspections

12.4.

GLP inspections Disclosure of information related to GLP inspections will not be published as it undermines the purpose of such inspections

13.

Innovation Task Force

13.1.

Minutes of Innovation Task Force Action: For information

13.2.

Innovation Task Force briefing meetings Disclosure of information related to briefing meetings taking place with applicants cannot be released at present time as deemed to contain commercially confidential information Scope: ITF Briefing Meeting Meeting date: 22 June 2016

Committee for medicinal products for human use (CHMP) EMA/CHMP/349943/2016

Page 25/34

Action: For adoption Scope: ITF Briefing Meeting Meeting date: 1 June 2016 Action: For adoption Scope: ITF Briefing Meeting Meeting date: TBD Action: For adoption Scope: ITF Briefing Meeting Meeting date: 17 June 2016 Action: For adoption Scope: ITF Briefing Meeting Meeting date: 4 July 2016 Action: For adoption Scope: ITF Briefing Meeting Meeting date: TBD Action: For adoption Scope: ITF Briefing Meeting Meeting date: 25 May 2016 Action: For adoption

13.3.

Requests for CHMP Opinion under Article 57(1)J and (1)P of Regulation (EC) No 726/2004 Request from EDQM for EMA scientific Opinion under Art. 57 (1)J of Regulation (EC) No 726/2004 Scope: Timetable Action: For adoption Request from the European Commission for an EMA scientific Opinion under Article 57 Scope: Timetable Action: For adoption

Committee for medicinal products for human use (CHMP) EMA/CHMP/349943/2016

Page 26/34

13.4.

Nanomedicines activities

14.

Organisational, regulatory and methodological matters

14.1.

Mandate and organisation of the CHMP

14.1.1.

Confirmation of area of expertise of Co-opted Member Action: For discussion Mandate of Sol Ruiz and Jean-Louis Robert expires in July 2016. Sol Ruiz’s area of expertise has been in Quality (biotech and biological), with expertise in advanced therapies (gene, cell and tissue therapies) and Jean-Louis Robert’s in Quality (nonbiologicals, synthetic chemicals). Comment from Spanish delegation on area of expertise

14.1.2.

Assessment Report templates for Generic products Scope: Proposal to amend assessment report templates for Generic products. Action: For discussion

14.1.3.

Feedback from recent interactions on evaluation management Action: For discussion

14.1.4.

Confirmation of joint CHMP/PDCO membership for Hungary, Romania, Luxembourg Hungary - Agnes Gyurasics and Melinda Sobor Romania - Nela Vilceanu and Dana Gabriela Marin Luxembourg - Jacqueline Genoux-Hames and Carola de Beaufort Action: For adoption

14.1.5.

Update on the “CHMP assessment report on the significant clinical benefit in comparison with existing therapies in accordance with Article 14(11) of Regulation (EC) No 726/2004” and “Practical guidance on elements required to grant an additional year of marketing protection due to significant clinical benefit” Action: For information

Committee for medicinal products for human use (CHMP) EMA/CHMP/349943/2016

Page 27/34

14.2.

Coordination with EMA Scientific Committees

14.2.1.

Pharmacovigilance Risk Assessment Committee (PRAC) Summary of recommendations and advice of PRAC meeting held on 10-13 May 2016 Action: For information List of Union Reference Dates and frequency of submission of Periodic Safety Update Reports (EURD list) for May 2016 Action: For adoption

14.2.2.

Committee for Advanced Therapies (CAT) CAT draft minutes of meeting held on 19-20 May 2016 Action: For information

14.2.3.

Committee for Herbal Medicinal Products (HMPC ) Not applicable this month

14.2.4.

Paediatric Committee (PDCO) PIPs reaching D30 at May 2016 PDCO Action: For information Report from the PDCO meeting held on 25-27 May 2016 Action: For information

14.2.5.

Committee for Orphan Medicinal Products (COMP) Report from the COMP meeting held on 17-19 May 2016 Action: For information

14.2.6.

Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) Report from the Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) on the meeting held on 23-25 May 2016 Action: For information Response from PKWP to question from the CMDh on bioequivalence for generic ibuprofen products Action: For adoption

Committee for medicinal products for human use (CHMP) EMA/CHMP/349943/2016

Page 28/34

14.2.7.

Committee for Medicinal Products for Veterinary Use (CVMP) Scope: “Updated scientific advice on the use of colistin products in animals within the European Union: development of resistance and possible impact on human and animal health Action: For adoption for public consultation until 2 June 2016

14.3.

Coordination with EMA Working Parties/Working Groups/Drafting Groups

14.3.1.

Scientific Advice Working Party (SAWP) Report from the SAWP meeting held on 10-13 May 2016. Table of conclusions Action: For information Scientific advice letters: Disclosure of information related to scientific advice letters cannot be released at present time as these contain commercially confidential information. Election of SAWP Vice Chair Action: For adoption

14.3.2.

Gastroenterology Drafting Group Nomination of observer – Mari Thorn (DE) Action: For adoption

14.3.3.

Safety Working Party (SWP) Pulegone and Menthofurane – SWP responses to HMPC/CHMP questions on the HMPC public statement (EMA/CHMP/SWP/305366/2016) Action: For adoption

14.3.4.

Radiopharmaceutical Drafting Group (RDG) Chair: Patrick Salmon Scope: Guideline on core SmPC and Package Leaflet for Fluorodopa (EMA/CHMP/337958/2016) Action: For adoption for 4 months public consultation Scope: Guideline on core SmPC and Package Leaflet for gadoteric acid (EMA/CHMP/337820/2016)

Committee for medicinal products for human use (CHMP) EMA/CHMP/349943/2016

Page 29/34

Action: For adoption for 4 months public consultation Scope: Guideline on core SmPC and Package Leaflet for (68Ge/68Ga) generator (EMA/CHMP/337681/2016) Action: For adoption for 4 months public consultation

14.4.

Cooperation within the EU regulatory network

14.5.

Cooperation with International Regulators

14.5.1.

International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Scope: ICH E11 (R) 1 Presentation by Daniel Brasseur Action: For information Scope: Appointment of Piotr Krauze as an Expert representing EU for ICH Q12, replacing David Cockburn in this role Action: For adoption Scope: S3A Q&A - Step 2 - Note for guidance on toxicokinetics the assessment of systemic exposure in toxicity studies - questions and answers (EMA/CHMP/ICH/320985/2016) Action: For adoption Scope: Guideline on enhancing the format and structure of benefit-risk information in ICH Efficacy - M4E(R2) Action: For information

Committee for medicinal products for human use (CHMP) EMA/CHMP/349943/2016

Page 30/34

14.6.

Contacts of the CHMP with external parties and interaction with the Interested Parties to the Committee

14.7.

CHMP work plan

14.8.

Planning and reporting

14.9.

Others

15.

Any other business

15.1.

AOB topic

Committee for medicinal products for human use (CHMP) EMA/CHMP/349943/2016

Page 31/34

16.

Explanatory notes

The notes below give a brief explanation of the main sections and headings in the CHMP agenda and should be read in conjunction with the agenda or the minutes. Oral explanations (section 2) The items listed in this section are those for which marketing authorisation holders (MAHs) or applicants have been invited to the CHMP plenary meeting to address questions raised by the Committee. Oral explanations normally relate to on-going applications (section 3, 4 and 5) or referral procedures (section 10) but can relate to any other issue for which the CHMP would like to discuss with company representatives in person. Initial applications (section 3) This section lists applications for marketing authorisations of new medicines that are to be discussed by the Committee. Section 3.1 is for medicinal products nearing the end of the evaluation and for which the CHMP is expected to adopt an opinion at this meeting on whether marketing authorisation should be granted. Once adopted, the CHMP opinion will be forwarded to the European Commission for a final legally binding decision valid throughout the EU. The other items in the section are listed depending on the stage of the evaluation, which is shown graphically below:

The assessment of an application for a new medicine takes up to 210 ‘active’ days. This active evaluation time is interrupted by at least one ‘clock-stop’ during which time the applicant prepares the answers to questions from the CHMP. The clock stop happens after day 120 and may also happen after day 180, when the CHMP has adopted a list of questions or outstanding issues to be addressed by the company. Related discussions are listed in the agenda under sections 3.2 (Day 180 List of outstanding issues) and 3.3 (Day 120 list of questions). CHMP discussions may also occur at any other stage of the evaluation, and these are listed under section 3.4, update on ongoing new applications for centralised procedures. The assessment leads to an opinion from the CHMP by day 210. Following a CHMP opinion the European Commission takes usually 67 days to issue a legally binding decision (i.e. by day 277 of the procedure). CHMP discussions on products that have received a CHMP opinion and are awaiting a decision are listed under section 3.6, products in the decision making phase. Extension of marketing authorisations according to Annex I of Reg. 1234/2008 (section 4) Extensions of marketing authorisations are applications for the change or addition of new strengths, Committee for medicinal products for human use (CHMP) EMA/CHMP/349943/2016

Page 32/34

formulations or routes of administration to existing marketing authorisations. Extension applications follow a 210-day evaluation process, similarly to applications for new medicines (see figure above). Type II variations - Extension of indication procedures (section 5) Type II variations are applications for a change to the marketing authorisation which requires an update of the product information and which is not covered in section 4. Type II variations include applications for a new use of the medicine (extension of indication), for which the assessment takes up to 90 days. For the applications listed in this section, the CHMP may adopt an opinion or request supplementary information from the applicant. Ancillary medicinal substances in medical devices (section 6) Although the EMA does not regulate medical devices it can be asked by the relevant authorities (the so-called Notified Bodies) that are responsible for regulating these devices to give a scientific opinion on a medicinal substance contained in a medical device. Re-examination procedures (new applications) under article 9(2) of regulation no 726/2004 (section 3.5) This section lists applications for new marketing authorisation for which the applicant has requested a re-examination of the opinion previously issued by the CHMP. Re-examination procedures (section5.3) This section lists applications for type II variations (including extension of indication applications) for which the applicant has requested re-examination of the opinion previously issued by the CHMP. Withdrawal of application (section 3.7) Applicants may decide to withdraw applications at any stage during the assessment and a CHMP opinion will therefore not be issued. Withdrawals are included in the agenda for information or discussion, as necessary. Procedure under article 83(1) of regulation (EC) 726/2004 (compassionate use) (section 7) Compassionate use is a way of making available to patients with an unmet medical need a promising medicine which has not yet been authorised (licensed) for their condition. Upon request, the CHMP provides recommendations to all EU Member States on how to administer, distribute and use certain medicines for compassionate use. Pre-submission issues (section 8) In some cases the CHMP may discuss a medicine before a formal application for marketing authorisation is submitted. These cases generally refer to requests for an accelerated assessment for medicines that are of major interest for public health or can be considered a therapeutic innovation. In case of an accelerated assessment the assessment timetable is reduced from 210 to 150 days. Post-authorisation issues (section 9) This section lists other issues concerning authorised medicines that are not covered elsewhere in the agenda. Issues include supply shortages, quality defects, some annual reassessments or renewals or type II variations to marketing authorisations that would require specific discussion at the plenary.

Committee for medicinal products for human use (CHMP) EMA/CHMP/349943/2016

Page 33/34

Referral procedures (section 10) This section lists referrals that are ongoing or due to be started at the plenary meeting. A referral is a procedure used to resolve issues such as concerns over the safety or benefit-risk balance of a medicine or a class of medicines. In a referral, the EMA is requested to conduct a scientific assessment of a particular medicine or class of medicines on behalf of the EU. Further information on such procedures can be found here. Pharmacovigilance issues (section 11) This section lists issues that have been discussed at the previous meeting of the PRAC, the EMA’s committee responsible for evaluating and monitoring safety issues for medicines. Feedback is provided by the PRAC. This section also refers to the early notification system, a system used to notify the European regulatory network on proposed EMA communication on safety of medicines. Inspections Issues (section 12) This section lists inspections that are undertaken for some medicinal products. Inspections are carried out by regulatory agencies to ensure that marketing authorisation holders comply with their obligations. Inspection can relate to good manufacturing practice (GMP), good clinical practice (GCP), good laboratory practice (GLP) or good pharmacovigilance practice (GVP). Innovation task force (section 13) The Innovation Task Force (ITF) is a body set up to encourage early dialogue with applicants developing innovative medicines. Minutes from the last ITF meeting as well as any related issue that requires discussion with the CHMP are listed in this section of the agenda. Further information on the ITF can be found here. Scientific advice working party (SAWP) (section 14.3.1) This section refers to the monthly report from the CHMP’s Scientific Advice Working Party (SAWP) on scientific advice given to companies during the development of medicines. Further general information on SAWP can be found here. Satellite groups / other committees (section 14.2) This section refers to the reports from groups and committees making decisions relating to human medicines: the Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh), the Committee for Orphan Medicinal Products (COMP), the Committee for Herbal Medicinal Products (HMPC), Paediatric Committee (PDCO), the Committee for Advanced Therapies (CAT) and the Pharmamacovigilance Risk Assessment Committee (PRAC). Invented name issues (section 14.3) This section list issues related to invented names proposed by applicants for new medicines. The CHMP has established the Name Review Group (NRG) to perform reviews of the invented names. The group's main role is to consider whether the proposed names could create a public-health concern or potential safety risk. Further information can be found here.

More detailed information on the above terms can be found on the EMA website: www.ema.europa.eu/

Committee for medicinal products for human use (CHMP) EMA/CHMP/349943/2016

Page 34/34

CHMP agenda of the 23-26 May 2016 meeting - European Medicines ...

May 23, 2016 - Extension of marketing authorisation according to Annex I of. Commission Regulation (EC) No ..... Early Notification System. ..... injection in cartridge, for subcutaneous (SC) administration by an automated mini-doser device.”.

304KB Sizes 2 Downloads 195 Views

Recommend Documents

CHMP agenda of the 23-26 May 2016 meeting - European Medicines ...
May 23, 2016 - Send a question via our website www.ema.europa.eu/contact ...... addition, the Marketing authorisation holder (MAH) took the opportunity to make minor .... double-blind, randomised-withdrawal, parallel group study (GO KIDS).

CHMP May 2017 Agenda for publication - European Medicines Agency
May 15, 2017 - Package Leaflet and the RMP are updated in accordance. .... and rituximab based on the results of the primary analysis of pivotal Study ...

CHMP May 2017 Agenda for publication - European Medicines Agency
May 15, 2017 - Send a question via our website www.ema.europa.eu/contact ... Additional details on some of these procedures will ...... Any other business. 32.

Minutes of the CHMP meeting 23-26 May 2016 - European Medicines ...
Jun 24, 2016 - Send a question via our website www.ema.europa.eu/contact. © European Medicines ... also be available. Of note, this agenda is a ...... Lovenox and associated names – enoxaparin - EMEA/H/A-30/1429 ................................ 33

Minutes of the CHMP meeting 23-26 May 2016 - European Medicines ...
Jun 24, 2016 - Initial applications; Day 180 list of outstanding issues . ...... scientific advice given to companies during the development of medicines. Further ...

Agenda - CHMP agenda of the 10-13 October 2016 meeting
Oct 10, 2016 - Send a question via our website www.ema.europa.eu/contact. © European Medicines ... also be available. Of note, this agenda is a ...... Lovenox and associated names – enoxaparin - EMEA/H/A-30/1429 ................................ 27

Agenda - CHMP agenda of the 20-23 June 2016 meeting
Jun 20, 2016 - Send a question via our website www.ema.europa.eu/contact. © European ..... Initial applications in the decision-making phase . ...... Scope: Draft agenda of BSWP meeting to be held by teleconference on 14 June 2016.

Agenda - CHMP agenda of the 7-10 November 2016 meeting
Nov 7, 2016 - Send a question via our website www.ema.europa.eu/contact ...... Ultragenyx UK Limited; treatment of Hereditary Inclusion Body Myopathy (HIBM) ...... main role is to consider whether the proposed names could create a ...

Agenda - CHMP agenda of the 12-15 September 2016 meeting
Sep 12, 2016 - updated and the Package Leaflet is proposed to be updated accordingly. ..... of a detailed analysis on a safety meta-analysis reporting a higher.

Agenda - CHMP agenda of the 20-23 June 2016 meeting
Jun 20, 2016 - Send a question via our website www.ema.europa.eu/contact. © European Medicines Agency ...... Contacts of the CHMP with external parties and interaction with the Interested. Parties to the ... Any other business. 33. 15.1.

Agenda - CHMP agenda of the 7-10 November 2016 meeting
Nov 7, 2016 - Send a question via our website www.ema.europa.eu/contact. © European Medicines ... be available. Of note, this agenda is a ..... Haldol and associated names - haloperidol - EMEA/H/A-30/1393 ................................... 22.

Agenda - CHMP agenda of the 12-15 September 2016 meeting
Sep 12, 2016 - Send a question via our website www.ema.europa.eu/contact. © European ...... Contacts of the CHMP with external parties and interaction with the Interested Parties to the Committee . ... Any other business. 37. 15.1.

Agenda - CHMP agenda of the 10-13 October 2016 meeting
Oct 10, 2016 - Revision of the 'Guideline on strategies to identify and mitigate risks for first-in-human clinical trials with ...... compliance with requests in the RMP adopted at the time of MA, the ..... encodes for the human ADA cDNA sequence.

Agenda - CHMP agenda of the 18-21 July 2016 meeting - European ...
Jul 18, 2016 - EMA/CHMP/490374/2016 Procedure Management and Committees Support Division ...... Decentralised Procedure number: UK/H/5906/001/DC ..... ADIENNE S.r.l. S.U.; treatment of graft-versus-host disease ...... Inspection can relate to good ma

CHMP agenda of the 11-14 September 2017 meeting - European ...
Sep 11, 2017 - Any other business. 38. 15.1. .... treatment of breast cancer, non-small cell lung cancer, renal cell cancer, advanced epithelial ..... Rapporteur: Johann Lodewijk Hillege, Co-Rapporteur: Alar Irs, PRAC Rapporteur: Kimmo.

CHMP agenda of the 11-14 September 2017 meeting - European ...
Sep 11, 2017 - Extension of marketing authorisation according to Annex I of. Commission ...... H. ANNEX H - Product Shared Mailboxes – e-mail address .

Agenda - CHMP agenda of the 18-21 July 2016 meeting - European ...
Jul 18, 2016 - Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5520. Send a question via our website www.ema.europa.eu/contact ...... Semler Research Centre Private Ltd - EMEA/H/A-31/1443 . ... Early Notification System .

Agenda - HMPC agenda of the 30-31 May 2016 meeting - European ...
May 27, 2016 - Joint CVMP/CHMP ad hoc expert group meeting on 3Rs (JEG 3Rs ..... Documents: Presentations; Email from HMPC Chair, 26 May 2016; ...

Minutes of the CHMP meeting 7-10 November 2016 - European ...
Dec 16, 2016 - Initial applications; List of outstanding issues (Day 180; Day 120 for ...... Post-meeting note: The company withdrew the application on 16 ...

CHMP Agenda November 2017 for publication - European Medicines ...
Nov 6, 2017 - Some of the information contained in this agenda is considered commercially confidential or sensitive and therefore not disclosed. With regard to intended therapeutic indications or procedure scopes listed against products, it must be n

CHMP Agenda November 2017 for publication - European Medicines ...
Nov 6, 2017 - Some of the information contained in this agenda is considered commercially confidential or sensitive and therefore not disclosed. With regard to intended therapeutic indications or procedure scopes listed against products, it must be n

Minutes of the CHMP meeting 25-28 April 2016 - European Medicines ...
May 27, 2016 - In accordance with the Agency's health and safety policy, delegates are to be briefed ..... Re-examination procedure of extension of marketing authorisation according to .... Direct-acting antivirals (DAAV) indicated for the treatment

Minutes of the CHMP meeting 20-23 June 2016 - European Medicines ...
Jul 22, 2016 - Send a question via our website www.ema.europa.eu/contact. © European Medicines ... be available. Of note, this agenda is a ..... Saroten and associated names - amitriptyline - EMEA/H/A-30/1430 ............................... 34. 10.6

Agenda - HMPC agenda of the 30-31 May 2016 meeting - European ...
May 27, 2016 - Coordination with CMDh – Addendum to the QRD templates for SmPC, Labelling and Patient. Leaflet on .... Any other business. 10. 6.1. .... Documents: Presentations; Email from HMPC Chair, 26 May 2016; Summary in.